AZD8601 EPICCURE Phase II trial demonstrated safety and tolerability in patients with heart failure

Positive Phase IIa results from the EPICCURE trial demonstrated that AZD8601 met the primary endpoint of safety and tolerability in patients with heart failure.

In the trial, researchers injected mRNA encoding vascular endothelial growth factor (VEGF-A) – known as AZD8601 – directly into the myocardium of patients undergoing elective coronary artery bypass surgery (CABG) surgery. AZD8601 is being co-developed with Moderna.

In the study of 11 patients, seven were treated with AZD8601 and four received placebo injections. Trends were observed in the three exploratory efficacy endpoints: left ventricular ejection fraction (LVEF); NT-proBNP (a biomarker which measures the level of a hormone and is elevated in patients with heart failure); and functional patient reported outcomes, compared with placebo.

VEGF-A is a paracrine factor important for new blood vessel formation. In addition, it has been shown to stimulate progenitor cell division, descendants of stem cells that when stimulated differentiate to create specialized cell types that contribute to repair and regeneration of the heart.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Over one billion heart cells can be lost during a heart attack. These early results indicate the potential of mRNA therapeutics in stimulating VEGF-A production to provide reparative and disease-modifying options for patients with heart failure and other ischaemic vascular diseases.”

Stéphane Bancel, Chief Executive Officer, Moderna, said: “mRNA is a compelling therapeutic modality because of its ability to act locally and transiently while driving dose-dependent protein expression. The results presented today are a result of pushing new boundaries in the treatment of cardiovascular and other ischaemic vascular diseases and address serious unmet needs with the goal of improving patients’ lives."

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